NCT06885944

Brief Summary

Probiotics will be used for preterm infants under 32 weeks of gestation and under 1500 g birthweight. Our aim was to investigate the effects of probiotics for stable preterm infants after extubation and who reached full enteral feeding. There are some hesitations among care-givers to start probiotics early due to safety issues although there are many positive effects of these products reported int the literature.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

March 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 10, 2025

Last Update Submit

March 13, 2025

Conditions

Preterm Infant Feeding OutcomesProbiotic

Outcome Measures

Primary Outcomes (1)

  • Antropometric measures

    daily weight gain mg/kg/day

    2 months

Secondary Outcomes (1)

  • Metabolic profile

    2 months

Study Arms (1)

Group 1

Preterm infants receiving probiotics

Dietary Supplement: Probiotic mix preparationDietary Supplement: Bifidobacteria

Interventions

Probiotic mix preparationDIETARY_SUPPLEMENT

Bifidobacterium containing supplement with vitamin D will start after preterm infants reaches full enteral feeding

Group 1
BifidobacteriaDIETARY_SUPPLEMENT

Rather than early period we will start probiotics after infant receive full enteral feedings

Group 1

Eligibility Criteria

Age7 Days - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

preterm infants with a gestational age lower than 32 weeks and 1500 g of birthweight, reached to fully enteral feeds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • FUAT EMRE CANPOLAT, MD

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seray Ozturk, MD

CONTACT

+905310843200serayakbag@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 20, 2025

Study Start

March 30, 2025

Primary Completion

September 30, 2025

Study Completion

November 30, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03